Cell Therapy ManufacturingCONNECT WITH AN EXPERT
World-class capabilities delivering capacity to patients waiting for treatments
While cell therapies continue to advance at a rapid pace, capacity to produce these life-saving therapies has been challenged leading to eligible patients succumbing to disease while on the waitlist for treatment. Center for Breakthrough Medicines (CBM) is a CDMO dedicated to bringing capabilities to the full cell therapy manufacturing process from early development to large-scale commercial production to eliminate existing bottlenecks, so patients get the treatment they need. Our team has unparalleled prior experience in advancing cell therapies to IND and all the way to commercialization, and our clients can leverage our large single source facility, capable of fully integrated production, with flexible, forward-engineered suites and client-centric program management.
Integrated capabilities to accelerate the development of autologous and allogeneic therapies
GMP workflows and equipment support a range of cell therapies
World-class processes and production platforms
For autologous cell therapy products, we employ sophisticated scheduling, supply chain and inventory control systems aligned with in-process testing, quality control, and lot release programs to overcome manufacturing challenges. A structured process ensures integrity through Chain of Identity and Chain of Custody from receipt of donor/patient material to processing, storage, and shipment back to the Authorized Treatment Centers.
For allogeneic cell therapy products, well-characterized cell banks may be scaled up with suspension systems using single-use bioreactors from 20L to 500L to meet clinical and commercial demand for the cell products.
The manufacture of the final material is based on the drug product process, determined by route of administration, target tissue, clinical protocol, and patient population. World-class Manufacturing Execution and Quality systems minimize manufacturing hiccups while streamlining efficiency enabling parallel batch processing and reducing manual data entry and review times by 50-70%. This translates to
- 40% reduction in OPEX per cleanroom for our clients
- 30-40 additional manufacturing days saved for incremental dose capacity
- CAR-T Cells
- Dendritic Cell & NK Cell
- Mesenchymal Stem Cells
- Hematopoietic Stem Cells
CBM supports clients with agile, flexible cell therapy capabilities
Rapid development and full program transparency
Our process development team begins by transferring in knowledge from our client, followed by work to ensure a robust and scalable process. CBM's platform enables clients to reduce the development timeline and deliver for patients sooner. We map the entire journey of your product from early development to commercialization, building in the requisite milestones to track progress and ensure quality all the way down the path. We are fully transparent in our partnerships, with an experienced program management team giving you clear oversight of your project through regular updates, on-site access, and the potential for dedicated office space with our Partner-in-Plant program.
Our quality control (QC) team operates in direct conjunction with manufacturing for method transfer, optimization, qualification, and validation. The labs are directly adjacent to production for rapid and seamless cGMP testing. Core cell therapy methods include:
- qPCR, rapid micro methods, flow cytometry, ELISA, and automated cell counting.
- Incoming raw material, in-process and final product testing.
- Network of qualified contract testing laboratories to supplement in-house capabilities.
- Environmental, personnel and utility monitoring.
Contact us to discuss how CBM’s integrated capabilities can support your program
Viral Vector Manufacturing
CBM’s viral vector capabilities efficiently and consistently delivers high yields in AAV, Lentivirus, HSV and Adenovirus vectors, accelerating the development of new therapies.
Cell Therapy Manufacturing
CBM has one of cell therapy’s most experienced teams and the largest single site facility in the industry. There is no greater centralization of expertise.
Our Experienced Team
Our team brings a wealth of experience from biopharma and advanced therapy CDMOs, ensuring that there is no safer place for your product.